June 12th 2025
The warning letters deal with a range of violations involving items from personal hygienic products to mismarketed analgesics.
CHMP Gives Positive Opinion to Novo Nordisk Hemophilia Treatment
October 22nd 2024As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.
AstraZeneca’s Imfinzi Gets Expanded Indication in Lung Cancer on FDA Approval
August 29th 2024Phase III trial results showed that Imfinzi (durvalumab in combination with chemotherapy reduced the risk of recurrence, progression, or death by 32% in patients with resectable non-small cell lung cancer before and after surgery.
PCI Pharma Services Successfully Completes International Inspection of New Hampshire Campus
August 21st 2024The International Coalition of Medicines Regulatory Authorities’ new Collaborative Hybrid Inspection Pilot program allows a CDMO to gain approval from multiple countries simultaneously, as opposed to separately phased inspections from different corners of the globe.
Behind the Headlines: Mpox Resurges; Eli Lilly Adds CGT Facilities; FDA Updates
August 21st 2024This Behind the Headlines news roundup panel discussion covers news items such as the resurgence of mpox in Africa, “medical tourism” in India, Eli Lilly’s new Boston CGT facilities, and contract development and manufacturing organization (CDMO) projected growth rates for the 2023–2029 period, and the reasons behind them.